Comparison of central venous catheter opening time between flushing with normal saline and heparin lock in patients
Design
A randomized clinical trial of three groups with parallel groups and on 90 samples sorted using the site
https://www.random.org/integers
Settings and conduct
This research is a clinical trial of three groups, the samples of which are hospitalized patients in the special care departments of Hashminejad and Imam Reza and Ghaem Hospitals in Mashhad.
In patients whose central venous catheter has been in place for less than 24 hours, they are divided into three groups based on random allocation. In the first group, before clamping the duct, a solution of 30 units of heparin in a volume of 2 cc is injected into each duct and locked every 8 hours, and then the duct is clamped. 3 normal saline is washed every 8 hours.
To check the openness of the central vein catheter, return without blood pressure into the syringe by aspirating with a 10cc syringe indicates that the catheter is open, and on the contrary, the duration of the catheter is recorded in hours. The duration of study for each group is 72 hours. After that, the researcher codes the data and enters SPSS software for analysis.
Participants/Inclusion and exclusion criteria
All hospitalized patients over 18 years of age hospitalized in the intensive care unit, less than 24 hours have passed since the placement of a three-channel central vein catheter in the subclavian region or internal jugular vein.
Intervention groups
1. the channel of the central venous catheter is locked with a concentration of 30 units of heparin
2.the channel of the central venous catheter is locked with a concentration of 50 units of heparin
Control group: The catheter canal is washed with 10 cc of normal saline solutio
Main outcome variables
Catheter duct opening/closing
The length of time the catheter duct remains open
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230228057559N1
Registration date:2023-03-07, 1401/12/16
Registration timing:prospective
Last update:2023-03-07, 1401/12/16
Update count:0
Registration date
2023-03-07, 1401/12/16
Registrant information
Name
Elahe Saffari khozani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3609 9125
Email address
saffarike982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of heparin lock and normal saline flushing on central venous catheter patency in patients admitted to the intensive care unit
Public title
Compare the effect of heparin lock and normal saline flushing on central venous catheter patency in patients admitted to the intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All hospitalized patients over 18 years of age hospitalized in the intensive care unit who have a central venous catheter
The patient's central venous catheter should be three ducts and the size of the catheter ducts should be 16, 18, 18.
The patient is treated with anticoagulants
Absence of obvious signs of infection at the catheter insertion site (discharge, redness, and swelling)
Place the catheter in the subclavian or internal jugular vein
The activated partial thromboplastin time (PTT) is within the normal range
Less than 24 hours have passed since the central venous catheter was inserted
At the beginning of the study, the site of catheter placement should be free of bleeding
Exclusion criteria:
Occurrence of infection symptoms at the catheter insertion site during the study
Unwanted exit of the catheter from its anatomical location, for example, due to the patient's restlessness
Bleeding at the catheter insertion site
The patient needs cardiopulmonary resuscitation
Occurrence of coagulation disorders and change of PTT outside the normal range
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of the research samples is such that all the people hospitalized in special care units, who have the conditions to enter the study, are selected as the research sample. A table was prepared for the order of patients entering the study.
At first, 30 numbers from one to three, 30 numbers from four to six, and 30 numbers from seven to nine were selected from random.org/integers. Then, to randomize this list of 90 numbers, the part related to randomization of lists, website random.org/lists was used. In this way, the patients entering the study are assigned a random number that determines the relevant group. Numbers 1 to 3 are for the normal saline group (group A) and numbers 4 to 6 are grouped for the heparin group with a concentration of 30 units (group B) and numbers 7 to 9 are grouped for the heparin group with a concentration of 50 units (group C).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients are not aware of their treatment method.
Based on the drug preparation protocol, the researcher prepares the studied solutions and codes them as A, B, C.
The interventionist (patient-specific nurse), without knowing the identity of these codes, injects solution A to patient A, and in the same way, the rest of the codes are also injected to the patient corresponding to their code.
The evaluator (patient-specific nurse) records the opening of the catheter with the corresponding specific code in the patient-specific form.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave, Mashhad Town
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-01-03, 1401/10/13
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.101
Health conditions studied
1
Description of health condition studied
Mechanical complications of central venous catheter in intensive care unit patients
ICD-10 code
T82.5
ICD-10 code description
Mechanical complication of other cardiac and vascular devices and implants
Primary outcomes
1
Description
The duration of the opening of the central venous catheter
Timepoint
The primary outcome (catheter patency) is checked every 8 hours. The length of time the catheter remains is recorded at the end of the study or when the catheter is blocked
Method of measurement
How to set the duration of the central venous catheter open is the clock.
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, a solution of 30 units of heparin (Alborz Daru Company) in a volume of 2 cc every 8 hours inside Each duct is injected and locked, and then the duct is clamped.The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded.
Category
Prevention
2
Description
The second intervention group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, a solution of 50 units of heparin (Alborz Daru Company) in a volume of 2 cc every 8 hours inside Each duct is injected and locked, and then the duct is clamped.The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded
Category
Prevention
3
Description
Control group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, they are flushed with a volume of 10 cc of normal saline every 8 hours and then The conduit is clamped. The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Hesam Sharifi Por Bahraman
Street address
Imam Reza Square, Ibn Sina Street , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
presidentoffice@mums.ac.ir
2
Recruitment center
Name of recruitment center
Hashminejad Hospital
Full name of responsible person
Hesam Sharifi Por Bahraman
Street address
End of Aburihan Blvd, Mufteh St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
5132742009
Phone
+98 51 3274 2009
Email
Hsh.pr@mums.ac.ir
3
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Hesam Sharifi Por Bahraman
Street address
The beginning of Ahmedabad St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Talaat Khadivzade
Street address
Ibn Sina St., Doctora Crossroads., University St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Saffari Khozani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina St., Doctora Crossroads., University St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Saffarike982@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohamad Hesam Sharifi Por Bahramen
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street., Doctor's Crossroads., University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
SharifiPM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Saffari Khozani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street., Doctor's Crossroads., University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3609 9125
Email
Saffarike982@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available